Archived - Important Safety Information Regarding The Discontinuation Of Sales - Linnefazodone In Canada: Letter To Pharmacists And Wholesalers

Starting date:

November 5, 2003

Posting date:

February 23, 2009

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-17000565

This is duplicated text of a letter from Linson Pharma.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

IMPORTANT SAFETY INFORMATION REGARDING THE DISCONTINUATION OF SALES - LinNefazodone IN CANADA: LETTER TO PHARMACISTS AND WHOLESALERS

October 2003

Dear Pharmacist / Wholesaler,

Immediate Attention Required

All Lots of LinNefazodone 50 mg, 100 mg, 150 mg, 200 mg

^* nefazodone hydrochloride, USP

As mentioned in the enclosed letter, as of November 27, 2003, the sales of LinNefazodone (nefazodone HCl) will be discontinued in Canada. In order to enhance patient safety and allow physicians the opportunity to counsel their patients concerning alternate treatment options, the product should be made available until November 27, 2003, at which time all distribution and dispensing must cease, so that no further sales should occur after November 27, 2003. In order to assist physicians in protecting the well being of their patients during this transition period, these products should be made available until November 27, 2003 and no product should be returned to Linson Pharma (Linson) at this time. Linson will be sending a second letter on November 27+1 day which will include a fax back form to identify all remaining inventory and a product credit form.

Please inform your customers that they should not discontinue taking LinNefazodone without first consulting with their physician. Please immediately refer any customer seeking LinNefazodone to their doctor for consultation.

If you have any questions about this discontinuation of sales, please call our Customer Services at 1-800-267-0005. We regret any inconvenience and appreciate your cooperation.

Any suspected adverse incident can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0201C2

OTTAWA, Ontario, K1A 1B9

Tel: (613) 957-0337 or Fax: (613) 957-0335

Toll free for consumers and health professionals:

Tel: 866 234-2345, Fax: 866 678-6789

cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the TPD web site or in The Canadian Compendium of Pharmaceuticals and Specialties.